510(k) · Cleared
ClearedElecsys Calcheck Cea
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Mar 6, 1997 as substantially equivalent to K963147 (Boehringer Mannheim Corp., 1996) after a 28-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it.
- Decided
- Mar 6, 1997
- Review
- 28 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K924862 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK924862 Aia-Pack HCG Calibration Verification Test SetTosoh Medics, Inc. · 1992
- 1 generation backK963147 Elecsys Calcheck TSHBoehringer Mannheim Corp. · 1996
- This deviceK970452 Elecsys Calcheck CeaBoehringer Mannheim Corp. · 1997
- Descendant · cites it directly · 0 of its ownK101856 Elecsys Cea Calcheck 5Roche Diagnostics · 2010
Most influential descendants
Showing 1 of 1 · See all- K101856Elecsys Cea Calcheck 5Roche Diagnostics · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K924862 | Aia-Pack HCG Calibration Verification Test Set | Tosoh Medics, Inc. | 1992 | — |
| −1 | K963147 | Elecsys Calcheck TSH | Boehringer Mannheim Corp. | 1996 | — |
| 0 (this device) | K970452 | Elecsys Calcheck Cea | Boehringer Mannheim Corp. | 1997 | — |
| +1 | K101856 | Elecsys Cea Calcheck 5 | Roche Diagnostics | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K963147 | Elecsys Calcheck TSHSummary page 1…name: Single (specified) analyte controls (assayed + unassayed) The Elecsys® CalCheck™ CEA is substantially equivalent to the currently marketed Elecsys® CalCheck™ TSH (K963147). The Elecsys® CalCheck™ CEA is a three level single analyte set of* lyophilized, human based materials. After reconstitution, t… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101856 | Elecsys Cea Calcheck 5 | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K101856 (Roche Diagnostics, 2010) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K963147.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Elecsys® CalCheck™ CEA is used to verify the calibration assignment for the Elecsys® CEA assay.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970452: Elecsys Calcheck Cea.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970452
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026